K233793
- 510(k) number
- K233793
- Device name
- CarboClear® X Pedicle Screw System
- Applicant
- CarboFix Orthopedics , Ltd. IL
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-08-01
- Date received
- 2023-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233793.pdf
Official FDA record: K233793
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.